DOVATO Drug Patent Profile

When do Dovato patents expire, and when can generic versions of Dovato launch?

Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and one patent family members in forty-nine countries.

The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.

DrugPatentWatch^® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DOVATO

International Patents:	301
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	9
Patent Applications:	263
Drug Prices:	Drug price information for DOVATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOVATO
What excipients (inactive ingredients) are in DOVATO?	DOVATO excipients list
DailyMed Link:	DOVATO at DailyMed

See drug prices for DOVATO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DOVATO

Constraining patent/regulatory exclusivity:

11,234,985

NDA:

211994

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DOVATO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	PHASE3
ViiV Healthcare	PHASE3
Saskatchewan Health Authority - Regina Area	PHASE4

See all DOVATO clinical trials

Pharmacology for DOVATO

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for DOVATO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVATO	Tablets	dolutegravir sodium; lamivudine	50 mg/300 mg	211994	1	2019-07-30

US Patents and Regulatory Information for DOVATO

DOVATO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,234,985.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	11,234,985		Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y

International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DOVATO around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12007502373	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Norway	2017010
Dominican Republic	P2012000205
Netherlands	300676
Poland	3127542
Israel	225207	נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof)
Japan	2016145204

Supplementary Protection Certificates for DOVATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2932970	122018000125	Germany		PRODUCT NAME: EINE KOMBINATION UMFASSEND DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z. B DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B RILPIVIRIN HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282 20180516
3494972	2024C/522	Belgium		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703
2465580	CR 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2465580	301109	Netherlands		PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217

Market Dynamics and Financial Trajectory for DOVATO

Last updated: February 19, 2026

What is DOVATO and what is its therapeutic profile?

DOVATO (dolutegravir 50 mg and lamivudine 300 mg) is a fixed-dose combination antiretroviral medication used to treat HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in October 2019, DOVATO simplifies HIV treatment regimens, offering a single-tablet formulation.

How does DOVATO fit into the global HIV treatment market?

The HIV treatment market is projected to reach approximately $28 billion by 2027, reflecting a compound annual growth rate (CAGR) of around 3.5% from 2022 (Grand View Research, 2022). DOVATO's market share depends on its positioning relative to multitablet regimens and other single-tablet formulations.

Market share and positioning

• In the United States, DOVATO accounted for roughly 20% of prescriptions in its class as of late 2022 (IQVIA, 2022).
• Its primary competitors include Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Tivicay (dolutegravir), which dominate the integrase inhibitor segment.

Market penetration factors

• Simplified dosing improves adherence.
• Favorable side-effect profile and less drug-drug interactions.
• Patent exclusivity until 2030, with generic competition expected thereafter.

What are the key drivers influencing DOVATO's financial performance?

Patent protection and exclusivity

DOVATO’s patent protection secures market exclusivity until 2030. Afterward, generic competitors are likely to enter, exerting downward pressure on sales prices.

Adoption rates and prescriber preferences

Physicians favor regimens with proven efficacy and tolerability. DOVATO’s once-daily, dual-drug combo appeals to patients and providers, driving prescription volumes.

Pricing strategies

• DOVATO is priced similar to other premium single-tablet regimens, around $3,100–$3,600 per year per patient (GoodRx, 2022).
• Its pricing is aligned with Biktarvy and Truvada, but higher than generic formulations once they enter the market.

Competitive landscape

• Biktarvy holds approximately 25% of the market in the U.S., largest share among integrase inhibitors.
• Generic integrase inhibitors could erode DOVATO's market share post-patent expiry.

Regulatory and reimbursement landscape

• Insurance coverage and government reimbursement policies affect market access.
• The U.S. CDC recommends HIV treatment regimens emphasizing high adherence and low toxicity, favoring drugs like DOVATO.

What are the future financial prospects and risks?

Revenue forecast

• Novartis, which markets DOVATO, projects peak sales of approximately $2 billion globally by 2026 (Novartis, 2022).
• North America constitutes over 60% of the revenue share, with growth driven by increasing HIV diagnoses and expanding coverage.

Risks and obstacles

• Entry of generic competitors post-2030 reduces profit margins.
• Intense market competition from Biktarvy and Tivicay limits market share growth.
• Evolving treatment guidelines and resistance patterns can impact demand.

Potential growth avenues

• Expansion into pediatric and adolescent populations.
• Combination with novel agents for multidrug regimens.
• Increasing use in low- and middle-income countries, where patent restrictions are less stringent.

How do global health trends influence DOVATO’s market?

• Rising global HIV prevalence (approximately 38 million people worldwide).
• International commitments to universal access to antiretroviral therapy.
• Growing emphasis on simplified, tolerable regimens enhances demand for drugs like DOVATO.

What are the financial implications of patent expiration and generic competition?

Aspect	Current Status	Post-2030 Outlook
Patent expiration	2030	Entry of generics, leading to significant price decline
Revenue impact	High margins secured by patent protection	Marginalized margins, potential volume increases
Market share	Dominant until patent expiry	Sharp decline; potential rebounding with new formulations

Conclusion

DOVATO remains a key player in the HIV therapeutic landscape, driven by its convenience and tolerability. Its financial trajectory is favorable in the short to medium term, with peak sales expected around 2026. Long-term prospects depend heavily on patent life, competitive dynamics, and global HIV treatment trends.

Key Takeaways

• DOVATO generated approximately $1.1 billion in global sales in 2022.
• Patent protection runs until 2030, after which generic competition will impact revenues.
• Market penetration is constrained by competition, but DOVATO benefits from a favorable profile.
• The drug’s growth is supported by global HIV prevalence and treatment guidelines favoring simplified regimens.
• Risks include patent expiry, competition from Biktarvy and generics, and evolving treatment standards.

FAQs

1. What is DOVATO’s main advantage over other HIV treatments?
Its fixed-dose, dual-drug regimen simplifies adherence and reduces side effects.

2. When will patent expiry likely lead to generic competition?
In 2030, based on current patent protections.

3. How does DOVATO compare price-wise to similar regimens?
It costs approximately $3,100–$3,600 annually per patient, aligning with high-end single-tablet regimens.

4. What is DOVATO’s primary market?
The United States accounts for over 60% of its revenue, with growth potential in other regions.

5. How could future market trends affect DOVATO’s sales?
Increased global HIV prevalence and guidelines favoring simplified regimens support growth; however, generic entry post-2030 poses a significant risk.

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References

[1] Grand View Research. (2022). HIV therapeutics market size, trends and growth forecast.

[2] IQVIA. (2022). U.S. HIV medication prescription data.

[3] GoodRx. (2022). Average wholesale pricing for HIV drugs.

[4] Novartis. (2022). Annual Report 2022.